Monjuvi, Minjuvi(tafasitamab)
Minjuvi, Monjuvi (tafasitamab) is an antibody pharmaceutical. Tafasitamab was first approved as Monjuvi on 2020-07-31. It is used to treat large b-cell lymphoma diffuse in the USA. It has been approved in Europe to treat large b-cell lymphoma diffuse. The pharmaceutical is active against B-lymphocyte antigen CD19.
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Commercial
Trade Name
FDA
EMA
Monjuvi
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Tafasitamab
Tradename | Proper name | Company | Number | Date | Products |
---|---|---|---|---|---|
Monjuvi | tafasitamab-cxix | MorphoSys US Inc. | N-761163 RX | 2020-07-31 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
monjuvi | Biologic Licensing Application | 2020-09-09 |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
tafasitamab, Monjuvi, MorphoSys US Inc. | |||
2027-07-31 | Orphan excl. |
Patent Expiration
No data
HCPCS
Code | Description |
---|---|
J9349 | Injection, tafasitamab-cxix, 2 mg |
Clinical
Clinical Trials
38 clinical trials
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Indications Phases 4
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 2 | 4 | — | — | — | 5 | |
Non-hodgkin lymphoma | D008228 | C85.9 | 3 | 4 | — | — | — | 5 | |
Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 1 | 2 | — | — | — | 2 | |
Prolymphocytic leukemia | D015463 | — | 1 | — | — | — | 1 | ||
Hodgkin disease | D006689 | C81 | — | 1 | — | — | — | 1 | |
Philadelphia chromosome | D010677 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | TAFASITAMAB |
INN | tafasitamab |
Description | Tafasitamab, sold under the brand name Monjuvi, is a medication used in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
|
Classification | Antibody |
Drug class | monoclonal antibodies |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
PDB | — |
CAS-ID | 1422527-84-1 |
RxCUI | — |
ChEMBL ID | CHEMBL4298047 |
ChEBI ID | — |
PubChem CID | — |
DrugBank | DB15044 |
UNII ID | QQA9MLH692 (ChemIDplus, GSRS) |
Target
Agency Approved
Alternate
No data
Variants
Clinical Variant
No data
Financial
Minjuvi - Incyte
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£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 301 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,244 adverse events reported
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